Head and Neck CancerNCT01114256
FNA Tumor Sampling for CD137 Modulation: A Pilot Study
An observational study of Head and Neck Cancer and Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to better understand the biology of the body's immune response to monoclonal antibody therapy for cancer. Your health information will be used to identify your tissues. The tissue we obtain may be useful for research or education, resulting in new drugs, therapies or diagnostic procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Head and Neck Cancer, Breast Cancer, Head and Neck Cancers
- What is being tested?
- FNA Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Stanford Cancer Center with lymphoma, squamous cell carcinoma of the head and neck, HER2+ breast adenocarcinoma, colorectal adenocarcinoma, or other solid tumor.
ALL Patients:
- Patient must have a lymphoma, squamous cell carcinoma of the head and neck, HER2+ breast adenocarcinoma, colorectal adenocarcinoma, or other solid tumor.
- Patients must not have received any immunosuppressive or anti cancer agent within 2 weeks prior to the first planned FNA biopsy.
- The patient's therapeutic plan must include a standard therapeutic monoclonal antibody (such as rituximab, cetuximab/panitumumab or trastuzumab) or an investigational monoclonal antibody) to be administered on a schedule such that a FNA biopsy can be done within one week prior, and/or peripheral blood drawn immediately prior to the first dose of the therapeutic mAb and immediately to 24-336 hours post dose. Patients not receiving any other anti- cancer or immunosuppressive (steroids) modality within that time frame are preferred, though use of such agents does not exclude them from the study.
- Patients not receiving any immunosuppressive or anti-cancer agent within 2 weeks prior to the first planned FNA biopsy are preferred.
- Informed consent must occur and be documented per institutional rules prior to the first planned FNA biopsy and blood draw.
Patients Providing an FNA in addition to Blood Samples: Criteria applicable to FNA, and not required for patients providing PBMCs without FNA. Patients without tumors amenable to FNA will be candidates for blood sampling only.
If patients do not meet inclusion criteria, then they will be excluded from participating in this study.
- Patients must have a normal WBC and platelet count, must have no evidence of coagulopathy and must not have received irreversible platelet inhibitors (aspirin) for 2 weeks and reversible platelet inhibitors (other NSAIDS) for one week prior to the initial FNA biopsy.
- Patients may not be taking therapeutic anticoagulation (target INR of >=2) (warfarin or heparin).
- Patients must have tumor masses amenable to minimally invasive fine needle aspiration by direct visualization and/ or palpation of the tumor. Generally this will be a biopsy of the primary tumor site or superficial regional lymph nodes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to better understand the biology of the body's immune response to monoclonal antibody therapy for cancer. Your health information will be used to identify your tissues. The tissue we obtain may be useful for research or education, resulting in new drugs, therapies or diagnostic procedures.
- Conditions
- Head and Neck Cancer, Breast Cancer, Head and Neck Cancers, Non-Hodgkin Lymphoma, Colorectal Adenocarcinoma
- Being tested
- FNA Biopsy
- Medical subject headings
- Head and Neck Neoplasms, Breast Neoplasms, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNA BiopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Fine needle aspiration (FNA) biopsies | Fine needle aspiration biopsies (FNA) will be performed prior to and 0 to 336 hours after the therapeutic monoclonal antibody infusion. Receives: Procedure: FNA Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of change in CD137 positive NK cells in blood & tumors in response to therapeutic moAbs
Measured: 12 months
Secondary outcomes (1)
Evaluation of activation status of CD137 positive NK cells
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. A. Dimitrios Colevas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114256
- Sponsor's protocol ID
- VAR0053
- Other IDs
- SU-04072010-5602
- Status last verified
- Aug 2017
- First submitted
- 23 Apr 2010
- Last updated
- 3 Aug 2017
- Results posted
- No
Publications
Makkouk A, Sundaram V, Chester C, Chang S, Colevas AD, Sunwoo JB, Maecker H, Desai M, Kohrt HE. Characterizing CD137 upregulation on NK cells in patients receiving monoclonal antibody therapy. Ann Oncol. 2017 Feb 1;28(2):415-420. doi: 10.1093/annonc/mdw570.
PubMed 27831501
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FNA Tumor Sampling for CD137 Modulation: A Pilot Study
- ClinicalTrials.gov ID
- NCT01114256
- Acronym / sponsor ID
- VAR0053
- Conditions
- Head and Neck Cancer, Breast Cancer, Head and Neck Cancers, Non-Hodgkin Lymphoma, Colorectal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand the biology of the body's immune response to monoclonal antibody therapy for cancer. Your health information will be used to identify your tissues. The tissue we obtain may be useful for research or education, resulting in new drugs, therapies or diagnostic procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fine needle aspiration (FNA) biopsies | – | Procedure: FNA BiopsyFine needle aspiration biopsies (FNA) will be performed prior to and 0 to 336 hours after the therapeutic monoclonal antibody infusion. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Stanford Cancer Center with lymphoma, squamous cell carcinoma of the head and neck, HER2+ breast adenocarcinoma, colorectal adenocarcinoma, or other solid tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FNA Biopsy | Procedure or surgery | Fine needle aspiration (FNA) biopsies |
Primary outcome
evaluation of change in CD137 positive NK cells in blood & tumors in response to therapeutic moAbs
Time frame: 12 months
1 secondary outcome
Evaluation of activation status of CD137 positive NK cells
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Derived from this study: PubMed 27831501Makkouk A, Sundaram V, Chester C, Chang S, Colevas AD, Sunwoo JB, Maecker H, Desai M, Kohrt HE. Characterizing CD137 upregulation on NK cells in patients receiving monoclonal antibody therapy. Ann Oncol. 2017 Feb 1;28(2):415-420. doi: 10.1093/annonc/mdw570.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. A. Dimitrios Colevas principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Breast Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of change in CD137 positive NK cells in blood & tumors in response to therapeutic moAbs (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01114256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.